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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Left Atrial Appendage Clip, Implantable
510(k) Number K234125
Device Name AtriClip FLEX-Mini LAA Exclusion System (ACHM)
Applicant
AtriCure, Inc.
7555 Innovation Way
Mason,  OH  45040
Applicant Contact Stephanie Hadnot
Correspondent
AtriCure, Inc.
7555 Innovation Way
Mason,  OH  45040
Correspondent Contact Stephanie Hadnot
Regulation Number878.4300
Classification Product Code
PZX  
Subsequent Product Code
FZX  
Date Received12/28/2023
Decision Date 07/29/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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